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    5.8. Pharmacopoeial Harmonisation 50800e

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    Giang Nguyen
    The document discusses harmonization efforts between the European Pharmacopoeia, Japanese Pharmacopoeia, and United States Pharmacopoeia. A group called the Pharmacopoeial Discussion Group works informally to harmonize general chapters and monographs. The goal is to make methods and requirements interchangeable between pharmacopoeias. For some products, complete harmonization is difficult but the group aims to harmonize as many attributes as possible. The pharmacopoeias have agreed not to make unilateral changes and instead revise harmonized texts simultaneously.

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    5.8. Pharmacopoeial Harmonisation 50800e

    Uploaded by

    Giang Nguyen
    224 views1 page
    The document discusses harmonization efforts between the European Pharmacopoeia, Japanese Pharmacopoeia, and United States Pharmacopoeia. A group called the Pharmacopoeial Discussion Group works informally to harmonize general chapters and monographs. The goal is to make methods and requirements interchangeable between pharmacopoeias. For some products, complete harmonization is difficult but the group aims to harmonize as many attributes as possible. The pharmacopoeias have agreed not to make unilateral changes and instead revise harmonized texts simultaneously.

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    5.8. pharmacopoeial harmonisation 50800e

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    The document discusses harmonization efforts between the European Pharmacopoeia, Japanese Pharmacopoeia, and United States Pharmacopoeia. A group called the Pharmacopoeial Discussion Group works informally to harmonize general chapters and monographs. The goal is to make methods and requirements interchangeable between pharmacopoeias. For some products, complete harmonization is difficult but the group aims to harmonize as many attributes as possible. The pharmacopoeias have agreed not to make unilateral changes and instead revise harmonized texts simultaneously.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    224 views1 page

    5.8. Pharmacopoeial Harmonisation 50800e

    Uploaded by

    Giang Nguyen
    The document discusses harmonization efforts between the European Pharmacopoeia, Japanese Pharmacopoeia, and United States Pharmacopoeia. A group called the Pharmacopoeial Discussion Group works informally to harmonize general chapters and monographs. The goal is to make methods and requirements interchangeable between pharmacopoeias. For some products, complete harmonization is difficult but the group aims to harmonize as many attributes as possible. The pharmacopoeias have agreed not to make unilateral changes and instead revise harmonized texts simultaneously.

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    © All Rights Reserved
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    of 1

    EUROPEAN PHARMACOPOEIA 6.0 5.8.

    Pharmacopoeial harmonisation

    01/2008:50800 Work on harmonisation is carried out by a well-defined but


    informal process in the Pharmacopoeial Discussion Group
    (PDG), in which the European Pharmacopoeia, the Japanese
    5.8. PHARMACOPOEIAL Pharmacopoeia and the United States Pharmacopoeia are
    associated. Information will be given in subsequent revised
    HARMONISATION versions of this general chapter on items that have been
    dealt with by the PDG.
    This general chapter is included for guidance of users. Where harmonisation of general chapters is carried out, the
    It provides information on the degree of harmonisation aim is to arrive at interchangeable methods or requirements
    and consequently interchangeability of various general so that demonstration of compliance using a general chapter
    chapters and monographs of the European Pharmacopoeia from one of the three pharmacopoeias implies that the same
    and those of the Japanese Pharmacopoeia and United result would be obtained using the general chapter of either
    States Pharmacopoeia. The chapter does not affect in any of the other pharmacopoeias. If residual differences remain
    way the status of the monographs and general chapters as in harmonised general chapters, information will be given in
    the authoritative reference in any case of doubt or dispute subsequent versions of this general chapter.
    where compliance with the European Pharmacopoeia is
    Where harmonisation of monographs is carried out, the aim
    required.
    is to arrive at identical requirements for all attributes of a
    The European Pharmacopoeia Commission recognises the product. For some products, it can be extremely difficult to
    utility of working with other pharmacopoeial bodies to achieve complete harmonisation, for example because of
    develop harmonised monographs and general chapters. differences in legal status and interpretation. It has therefore
    Such harmonisation is fully compatible with the declared appeared to the PDG worthwhile to approve and publish
    aims of the Commission and has benefits of different monographs in which as many attributes as possible are
    kinds, notably the simplification and rationalisation of harmonised. Information on any non-harmonised attributes
    quality control methods and licensing procedures. Such will be included in subsequent versions of this general
    harmonisation also enhances the benefits of the work of the chapter.
    International Conference on Harmonisation (ICH) and the The three Pharmacopoeias have undertaken not to make
    Veterinary International Co-operation on Harmonisation unilateral changes to harmonised monographs and general
    (VICH) since some of the guidelines developed depend on chapters but rather to apply the agreed revision procedure
    pharmacopoeial general chapters for their application. whereby all partners adopt a revision simultaneously.

    General Notices (1) apply to all monographs and other texts 645

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